Infusion Pump System

ABSTRACT

Some embodiments of a portable infusion pump system can be configured to can be configured to adjust the sensitivity of particular detectors or alert systems based (at least in part) on information received from a monitoring device. For example, a glucose monitoring device can communication with an infusion pump assembly used to supply insulin or another medication to a user. In such circumstances, the data received from the monitoring device can be used to adjust the sensitivity of an occlusion detection system.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This is a continuation of U.S. application Ser. No. 13/613,620 filedSep. 13, 2012 which is a continuation of U.S. application Ser. No.13/072,874 filed on Mar. 28, 2011 (now U.S. Pat. No. 8,277,435), whichis a divisional of U.S. application Ser. No. 12/115,008 filed on May 5,2008 (now U.S. Pat. No. 7,938,797), the entire contents of theseprevious applications are expressly incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to portable infusion pump systems to deliverfluids, such as insulin infusion pump systems or the like.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.

SUMMARY

Some embodiments of a portable infusion pump system can be configured tocan be configured to adjust the sensitivity of particular detectors oralert systems based (at least in part) on information received from amonitoring device. For example, a glucose monitoring device cancommunication with an infusion pump assembly used to supply insulin oranother medication to a user. In such circumstances, the data receivedfrom the monitoring device can be used to adjust the sensitivity of anocclusion detection system or another alert system arranged in theinfusion pump assembly. In one example, the infusion pump system can beconfigured increase the sensitivity of the occlusion detection systemwhen the information from the glucose monitoring device indicates thatthat the user's blood glucose is greater than a normal range. As such,the occlusion detection system can more promptly alert the user toinspect the medicine delivery path for a possible clog or kink, therebyproviding a timely remedy to the situation when insulin dispensation isan urgent concern (e.g., during the period of high blood glucoselevels).

In particular embodiments, a medical infusion pump system may include aportable pump housing that receives a medicine for dispensation to auser. The pump housing may at least partially contain a pump drivesystem to dispense the insulin medicine through a flow path to the user.The system may also include a controller that activates the pump drivesystem to dispense the insulin medicine from the portable pump housing.The controller may operate an occlusion detection system that detects afluid condition in the flow path. The occlusion detection system canhave an adjustable sensitivity. The controller may output an occlusionalarm to the user when an occlusion is detected in the flow path. Thesystem may further include a monitoring device that communicates glucoseinformation to the controller. The glucose information may be indicativeof a blood glucose level of the user. The sensitivity of the occlusiondetection system can be adjusted in response to the glucose informationreceived by the controller from the monitoring device.

Some embodiments may include a method of operating a medical infusionpump system. The method may include activating an occlusion detectionsystem to detect a fluid condition in a flow path extending from amedicine reservoir in a portable pump assembly to user. The pumpassembly may include a pump drive system to dispense medicine throughthe flow path to the user. The method may also include receiving glucoseinformation from a monitoring device. The glucose information may beindicative of a detected blood glucose level of the user. The method mayalso include adjusting a sensitivity of the occlusion detection systemin response to receiving the glucose information from the monitoringdevice. The method may also include outputting an occlusion alarm to theuser when an occlusion is detected in the flow path.

Some or all of the embodiments described herein may provide one or moreof the following advantages. First, some embodiments of an infusion pumpsystem can include a monitoring device that interacts with an infusionpump assembly so as to delivery insulin or another medication whilecontemporaneously monitoring a user's blood characteristic. For example,the monitoring device can be configured to wireless communicateinformation indicative of the user's blood glucose level to the infusionpump assembly while the pump assembly operates to dispense themedication to the user.

Second, some embodiments of the pump assembly can be configured toadjust the sensitivity of particular detectors or alert systems based(at least in part) on information received from the monitoring device.For example, the infusion pump assembly can include an occlusiondetection system with a controlled sensitivity, and the sensitivity ofthe occlusion detection system can be adjusted when the glucoseinformation received from the monitoring device indicates that theuser's glucose level is outside of a normal range. Such a feature can beuseful when the user's blood glucose level is greater than a normalrange, which creates an urgent concern for insulin dispensation and forprompt remedies to possible occlusions in the flow path.

Third, the infusion pump system can be configured to adjust thesensitivity of the occlusion detection system in a manner that decreasesthe likelihood of false alarms when blood glucose levels are in anacceptable range, while ensuring that the user is promptly alerted topossible occlusions when the blood glucose levels are dangerously high(e.g., at a time when insulin dispensation is an urgent concern). Inparticular circumstances, false alarms may be caused by transient kinksin the infusion set tubing that can self correct after a short period oftime. If occlusion alarms are activated too frequently when suchtransient kinks are present (especially when blood glucose levels aredetected within a normal range), the user may eventually choose toignore or disable such occlusion alarms (believing them to be falsealarms). Such a pattern could lead the user to mistakenly ignoreauthentic occlusion alarms and cause unsafe increases in blood glucoselevels. As described in more detail below, the infusion pump system canemploy a normal sensitivity setting for the occlusion detection systemwhen blood glucose levels are in an acceptable range, thereby reducingthe likelihood of false alarms during these periods of lower risk.However, the infusion pump system can employ a heightened sensitivitysetting for the occlusion detection system when blood glucose levels arehigher than a normal range, which can serve to promptly alert the userto possible occlusions at a time when insulin dispensation is an urgentconcern.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system includingocclusion detection and glucose monitoring in accordance with someembodiments.

FIG. 2 is a perspective exploded view of the infusion pump assembly ofFIG. 1.

FIG. 3 is a perspective view of the infusion pump system where the pumpassembly of FIG. 1 is worn on clothing of a user.

FIG. 4 is a perspective view of an infusion pump system where the pumpassembly is worn on skin of a user, in accordance with particularembodiments.

FIGS. 5-6 are perspective views of a pump device being detached from acontroller device, in accordance with some embodiments.

FIGS. 7-8 are perspective views of the pump device of FIGS. 5-6 beingdiscarded and the controller device of FIGS. 5-6 being reused with a newpump device.

FIG. 9 is an exploded perspective view of a controller device for aninfusion pump system, in accordance with some embodiments.

FIG. 10 is a perspective view of a portion of a pump device for aninfusion pump system, in accordance with particular embodiments.

FIG. 11A is a diagram depicting a fluid pressure curve as measured by apressure sensor, in accordance with some embodiments.

FIG. 11B is a diagram depicting the output of a pressure switch whenmeasuring a pressure curve as similar to that depicted in FIG. 11B, inaccordance with some embodiments.

FIG. 12 is a flow diagram depicting an exemplary process used todetermine when a user should be alerted to an occlusion, in accordancewith some embodiments.

FIGS. 13-16 are flow diagrams depicting exemplary processes used todetermine whether adjustments are to be made to the sensitivity of anocclusion detection system based (at least in part) on glucose data, inaccordance with some embodiments.

FIG. 17 is a perspective view of occlusion sensor circuitry for anoptical occlusion detection system, in accordance with some embodiments.

FIGS. 18-19 are diagrams of the occlusion sensor of FIG. 17.

FIG. 20 is a flow diagram depicting an exemplary process used todetermine when a user should be alerted to an occlusion, in accordancewith some embodiments.

FIG. 21 is a flow diagram depicting an exemplary process used todetermine whether adjustments are to be made to the sensitivity of anocclusion detection system based (at least in part) on glucose data, inaccordance with some embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, an infusion pump system 10 can include a glucosemonitoring device 50 in communication with an infusion pump assembly 60used to supply insulin or other medication to a user via, for example,an infusion set 70. In some embodiments, the monitoring device 50 can beconfigured to supply information indicative of a user's blood glucoselevel to the infusion pump assembly 60. Based at least in part on theinformation supplied from the monitoring device 50 to the infusion pumpassembly 60, the infusion pump assembly 60 can modify one or moreprocesses associated with tasks performed by the infusion pump system10. For example, in some embodiments, the pump assembly 60 can beconfigured to adjust the sensitivity of particular detectors or alertsystems based (at least in part) on information received from theglucose monitoring device 50. In addition, or in the alternative, thepump assembly 60 can be configured to adjust the basal delivery rate,bolus dosages and timing, and/or other tasks performed by the pumpassembly 60 based (at least in part) on information received from theglucose monitoring device 50.

In some embodiments, the glucose monitoring device 50 can include ahousing 52, a wireless communication device 54, and a sensor shaft 56.The wireless communication device 54 can be contained within the housing52 and the sensor shaft 56 can extend outward from the housing 52. Inuse, the sensor shaft 56 can penetrate the skin 20 of a user to makemeasurements indicative of characteristics of the user's blood (e.g.,the user's blood glucose level or the like). In response to themeasurements made by the sensor shaft 56, the glucose monitoring device50 can employ the wireless communication device 54 to transmit data tocontroller device 200 of the pump assembly 60.

In some embodiments, the monitoring device 50 may include a circuit thatpermits sensor signals (e.g., data from the sensor shaft 56) to becommunicated to the communication device 54. The communication device 54can transfer the collected data to the infusion pump assembly 60 (e.g.,by wireless communication to a communication device 247 arranged in thepump assembly 60). In some embodiments, the monitoring device 50 canemploy other methods of obtaining information indicative of a user'sblood characteristics and transferring that information to the infusionpump assembly 60. For example, an alternative monitoring device mayemploy a micropore system in which a laser porator creates tiny holes inthe uppermost layer of a user's skin, through which interstitial glucoseis measured using a patch. Alternatively, the monitoring device can useiontophoretic methods to non-invasively extract interstitial glucose formeasurement. In other examples, the monitoring device can includenon-invasive detection systems that employ near IR, ultrasound orspectroscopy and particular embodiments of glucose-sensing contactlenses. Invasive methods involving optical means of measuring glucosecould also be added. In yet another example, the monitoring device caninclude an optical detection instrument that is inserted through theskin for measuring the user's glucose level.

Furthermore, it should be understood that in some embodiments, themonitoring device 50 can be in communication with the pump assembly 60via a wired connection. In some embodiments of the pump system 10, teststrips (e.g., glucose test strips) containing a sample of the user'sblood can be inserted into a portion of the pump assembly 60 to betested for characteristics of the user's blood. Alternatively, the teststrips (e.g., glucose test strips) containing a sample of the user'sblood can be inserted into a glucose meter device, which then analyzesthe characteristics of the user's blood and communicates the information(via a wired or wireless connection) to the pump assembly 60. In otherembodiments, characteristics of the user's blood glucose information canbe entered directly into the pump system 10 via a user interface on thecontroller device 200.

Referring now to FIGS. 1-2, the infusion pump assembly 60 can include apump device 100 and the controller device 200 that communicates with thepump device 100. The pump device 100 includes a housing structure 110that defines a cavity 116 in which a fluid cartridge 120 can bereceived. The pump device 100 also includes a cap device 130 to retainthe fluid cartridge 120 in the cavity 116 of the housing structure 110.The pump device 100 includes a drive system (described in more detailbelow) that advances a plunger 125 in the fluid cartridge 120 so as todispense fluid therefrom. In some embodiments, the dispensed fluid exitsthe fluid cartridge 120, passes through a flexible tube 72 of theinfusion set 70 to a cannula housing 74. The dispensed fluid can enterthrough the skin via a cannula 76 attached to the underside of thecannula housing 74.

In some embodiments, the controller device 200 communicates with thepump device 100 to control the operation of the drive system. When thecontroller device 200, the pump device 100 (including the cap device130), and the fluid cartridge 120 are assembled together, the user can(in some embodiments) conveniently wear the infusion pump assembly 60 onthe user's skin under clothing or in the user's pocket while receivingthe fluid dispensed from the pump device 100.

The controller device 200 may be configured as a reusable component thatprovides electronics and a user interface to control the operation ofthe pump device 100. In such circumstances, the pump device 100 can be adisposable component that is disposed of after a single use. Forexample, the pump device 100 can be a “one time use” component that isthrown away after the fluid cartridge 120 therein is exhausted.Thereafter, the user can removably attach a new pump device 100 to thereusable controller device 200 for the dispensation of fluid from a newfluid cartridge 120. Accordingly, the user is permitted to reuse thecontroller device 200 (which may include complex or valuableelectronics) while disposing of the relatively low-cost pump device 100after each use. Such a pump assembly 60 can provide enhanced user safetyas a new pump device 100 (and drive system therein) is employed witheach new fluid cartridge 120.

Briefly, in use, the pump device 100 can be configured to removablyattach to the controller device 200 in a manner that provides a securefitting, an overall compact size, and a reliable electrical connection.In the example depicted in FIG. 1, the controller device 200 isremovably attached with the pump device 100 in a generally side-by-sideconfiguration while not fully surrounding the pump housing 110.Accordingly, the pump device 100 and the controller device 200 can beseparate components that fit together, but the overall size of thecombined assembly is reduced because there is no requirement for onecomponent (e.g., the controller device) to completely surround orenvelop the second component (e.g., the pump device). The compact sizepermits the infusion pump assembly 60 to be discrete and portable (asdescribed below in more detail in connection with FIGS. 3-4). Moreover,at least one of the pump device 100 or the controller device 200 mayinclude a release member that facilitates an easy-to-use detachment andreplacement process. For example, as described in more detail below inconnection with FIGS. 7-8, an exhausted pump device 100 may be a “onetime use” component that is discarded after being used, and a new pumpdevice 100′ (having a new medicine cartridge 120′) can thereafter beattached to the controller device 200.

Moreover, the pump device 100 and the controller device 200 can bemounted to one another so that the assembled pump assembly 60 isresistant to migration of external contaminants (e.g., water fromprecipitation or splashing, sweat, and the like) into the pump device100 or the controller device 200. In particular, the infusion pumpassembly 60 may include one or more seals that are arranged to hindermigration of external contaminants into the cavity of the pump device100 (e.g., to protect the insulin container 120 and the drive systemduring operation). Also, the infusion pump assembly 60 may include oneor more gaskets arranged proximate to the electrical connection location(between the pump device 100 and the controller device 200) to protectthe electrical connection from external contaminants. Thus, in someembodiments, the infusion pump system 10 can be assembled into a waterresistant configuration that protects sensitive components from watermigration (e.g., if the user encounters water while wearing the pumpassembly 60).

As described in more detail below, the pump assembly 60 can include asensor configuration that detects occlusions in the fluid flow pathextending to the user. In the embodiment depicted in FIGS. 1-2, thefluid flow path can include the delivery from the medicine cartridge120, through the cap 130, and through the infusion set 70. For example,the controller device 200 can communicate with a pressure sensor 380(refer to FIG. 10) arranged in the pump device 100 so as to detect highpressures created by occlusions. In another example, the controllerdevice 200 may include an optical sensor system 250 (refer to FIGS.17-19) that detects the amount of light reflected from a portion of thecap device 130. The optical sensor system 250 may include a number ofcomponents that are housed in the controller device 200. In one example,the light emitter and light sensor may be arranged on a sensor circuitin the controller device 200, thereby permitting these components to bereused along with the controller device (while the relatively low costcomponents in the pump device 100 are discarded after the “one time use”of the pump device 100).

It should be understood that, in alternative embodiments, the pumpdevice 100 and the controller device 200 can be configured as a singleunit in which the control components and the pump drive system arearranged in a single housing. In these alternative embodiments, the pumpassembly (including the controller device and the pump device) may havea different size and shape and may operate as a reusable unit that cancommunicate with a number of monitoring devices 50 over a period oftime.

Referring again to FIGS. 1-2, in some embodiments, the pump system 10 isa medical infusion pump system that is configured to controllablydispense a medicine from the cartridge 120. As such, the fluid cartridge120 may contain a medicine 126 to be infused into the tissue orvasculature of a targeted individual, such as a human or animal patient.For example, the pump device 100 can be adapted to receive a medicinecartridge 120 in the form of a carpule that is preloaded with insulin oranother medicine for use in the treatment of Diabetes (e.g., Byetta®,Symlin®, or others). Such a cartridge 120 may be supplied, for example,by Eli Lilly and Co. of Indianapolis, Ind. Other examples of medicinescontained in the fluid cartridge 120 include: pain relief drugs, hormonetherapy, blood pressure treatments, anti-emetics, osteoporosistreatments, or other injectable medicines. The fluid cartridge 120 mayhave other configurations. For example, the fluid cartridge may comprisea reservoir that is integral with the pump housing structure 110 (e.g.,the fluid cartridge can be defined by one or more walls of the pumphousing structure 110 that surround a plunger to define a reservoir inwhich the medicine is injected or otherwise received).

In some embodiments, the pump device 100 may include one or morestructures that interfere with the removal of the medicine cartridge 120after the medicine cartridge 120 is inserted into the cavity 116. Forexample, as shown in FIG. 2, the pump housing structure 110 may includeone or more retainer wings 119 that at least partially extend into thecavity 116 to engage a portion of the medicine cartridge 120 when themedicine cartridge 120 is installed therein. In this embodiment, thepump housing structure 110 includes a pair of opposing retainer wings119 (only one is shown in the view in FIG. 2) that flex toward the innersurface of the cavity 116 during insertion of the medicine cartridge120. After the medicine cartridge is inserted to a particular depth, theretainer wings 119 are biased to flex outward (toward the center of thecavity 116) so that the retainer wings 119 engage a neck portion 129 ofthe medicine cartridge 120. This engagement with the retainer wings 119and the neck portion 129 hinder any attempts to remove the medicinecartridge 120 away from the pump device 100. Alternative embodiments caninclude other features and/or configurations to hinder the removal ofthe medicine cartridge 120.

Embodiments of the pump device 100 that hinder the removal of themedicine cartridge 120 may facilitate the “one-time-use” feature of thepump device 100. Because the retainer wings 119 can interfere withattempts to remove the medicine cartridge 120 from the pump device 100,the pump device 100 will be discarded along with the medicine cartridge120 after the medicine cartridge 120 is emptied, expired, or otherwiseexhausted. The retainer wings 119 may serve to hinder attempts to removethe exhausted medicine cartridge 120 and to insert a new medicinecartridge 120 into the previously used pump device 100. Accordingly, thepump device 100 may operate in a tamper-resistant and safe mannerbecause the pump device 100 can be designed with predetermined lifeexpectancy (e.g., the “one-time-use” feature in which the pump device isdiscarded after the medicine cartridge 120 is emptied, expired, orotherwise exhausted).

Still referring to FIGS. 1-2, the cap device 130 can be joined with thepump device 100 after the medicine cartridge is inserted in the cavity116. It should be understood that the cap device 130 may supplement orreplace the previously described retainer wings 119 by locking intoposition after joining with the pump housing 110, thereby hinderingremoval of the fluid cartridge 120 in the pump housing 110. As shown inFIGS. 1-2, the cap device 130 may include an output port 139 thatconnects with the tubing 72 for dispensation of the medicine to theuser. In some embodiments, the output port 139 may have an angledorientation such that a portion of the tubing extends transversely tothe central axis of the cartridge 120 and cap device 130. The outputport 139 can be configured to mate with tubing 72 of the infusion set 70(FIG. 1).

Still referring to FIGS. 1-2, the controller device 200 may be removablyattached to the pump device 100 so that the two components aremechanically mounted to one another in a fixed relationship. Such amechanical mounting can form an electrical connection between theremovable controller device 200 and the pump device 100. For example,the controller device 200 may be in electrical communication with aportion of a drive system (described in connection with FIG. 10) of thepump device 100. As described in more detail below, the pump device 100includes a drive system that causes controlled dispensation of themedicine or other fluid from the cartridge 120. In some embodiments, thedrive system incrementally advances a piston rod longitudinally into thecartridge 120 so that the fluid is forced out of an output end 122. Theseptum 121 at the output end 122 of the fluid cartridge 120 can bepierced to permit fluid outflow when the cap device 130 is connected tothe pump housing structure 110. Thus, when the pump device 100 and thecontroller device 200 are attached and thereby electrically connected,the controller device 200 communicates electronic control signals via ahardwire-connection (e.g., electrical contacts or the like) to the drivesystem or other components of the pump device 100. In response to theelectrical control signals from the controller device 200, the drivesystem of the pump device 100 causes medicine to incrementally dispensefrom the medicine cartridge 120.

In some embodiments, the controller device is configured to removablyattach to the pump device 100 in a side-by-side arrangement. The compactsize permits the infusion pump assembly 60 to be discrete and portablewhen the pump device 100 is attached with the controller device 200 (asshown in FIG. 1). In this embodiment, the controller device 200 includesa controller housing structure 210 having a number of features that areconfigured to mate with complementary features of the pump housingstructure 110 so as to form a releasable mechanical connection(described below in more detail in connection with FIGS. 5-8). Suchmating features of the pump housing structure 110 and the controllerhousing structure 210 can provide a secure connection in the previouslydescribed side-by-side arrangement

As shown in FIG. 2, the pump device 100 may include an electricalconnector 118 (e.g., having conductive pads, pins, or the like) that areexposed to the controller device 200 and that mate with a complementaryelectrical connector (refer to connector 218 in FIG. 6) on the adjacentface of the controller device 200. The electrical connectors 118 and 218provide the electrical communication between the control circuitry(refer, for example, to FIG. 9) housed in the controller device 200 andat least a portion of the drive system or other components of the pumpdevice 100. In some exemplary embodiments, the electrical connectors 118and 218 permit the transmission of electrical control signals to thepump device 100 and the reception of feedback signals (e.g., sensorsignals) from particular components within the pump device 100.Furthermore, as described in more detail below, the infusion pumpassembly 60 may include a gasket 140 that provides a seal which isresistant to migration of external contaminants when the pump device 100is attached to the controller device 200. Thus, in some embodiments, thepump device 100 and the controller device 200 can be assembled into awater resistant configuration that protects the electricalinterconnection from water migration (e.g., if the user encounters waterwhile carrying the pump assembly 60).

Still referring to FIGS. 1-2, the controller device 200 includes a userinterface 220 that permits a user to monitor the operation of the pumpdevice 100. In some embodiments, the user interface 220 includes adisplay 222 and one or more user-selectable buttons (e.g., four buttons224 a, 224 b, 224 c, and 224 d in this embodiment). The display 222 mayinclude an active area in which numerals, text, symbols, images, or acombination thereof can be displayed (refer, for example, to FIG. 2).For example, the display 222 may be used to communicate a number ofalarms, settings, and/or menu options for the infusion pump system 10.In some embodiments, the display 222 can indicate the user's bloodglucose level, an indication that the user's blood glucose level isrising or falling, and if adjustments have been made to the sensitivityof an occlusion detection system. For example, FIG. 1 depicts anembodiment in which the display 222 alerts the user that the detectedblood glucose level is at 220 mg/dL, the blood glucose level is rising(as communicated by the upward facing arrow), and that the sensitivityof the occlusion detector has been adjusted due to the blood glucosedata detected by the monitoring device 50.

In some embodiments, the user may press one or more of the buttons 224a, 224 b, 224 c, and 224 d to shuffle through a number of menus orprogram screens that show particular settings and data (e.g., reviewdata that shows the medicine dispensing rate, the total amount ofmedicine dispensed in a given time period, the amount of medicinescheduled to be dispensed at a particular time or date, the approximateamount of medicine remaining in the cartridge 120, or the like). In someembodiments, the user can adjust the settings or otherwise program thecontroller device 200 by pressing one or more buttons 224 a, 224 b, 224c, and 224 d of the user interface 220. For example, in embodiments ofthe infusion pump system 10 configured to dispense insulin, the user maypress one or more of the buttons 224 a, 224 b, 224 c, and 224 d tochange the dispensation rate of insulin or to request that a bolus ofinsulin be dispensed immediately or at a scheduled, later time.

The display 222 of the user interface 220 may be configured to displayquick reference information when no buttons 224 a, 224 b, 224 c, and 224d have been pressed. For example, as shown in FIG. 2, the active area ofthe display 222 can display the time, date, insulin remaining inmedicine cartridge 120, blood glucose level, and an indication ofwhether the user's blood glucose level is rising or falling. Thisinformation can be displayed for a period of time after no button 224 a,224 b, 224 c, and 224 d has been actuated (e.g., five seconds, 10seconds, 30 seconds, 1 minute, 5 minutes, or the like). Thereafter, thedisplay 222 may enter sleep mode in which the active area is blank,thereby conserving battery power. In addition or in the alternative, theactive area can display particular device settings, such as the currentdispensation rate or the total medicine dispensed, for a period of timeafter no button 224 a, 224 b, 224 c, or 224 d has been actuated (e.g.,five seconds, 10 seconds, 30 seconds, 1 minute, 5 minutes, or the like).Again, thereafter the display 222 may enter sleep mode to conservebattery power. In certain embodiments, the display 222 can dim after afirst period of time in which no button 224 a, 224 b, 224 c, or 224 dhas been actuated (e.g., after 15 seconds or the like), and then thedisplay 22 can enter sleep mode and become blank after a second periodof time in which no button 224 a, 224 b, 224 c, or 224 d has beenactuated (e.g., after 30 seconds or the like). Thus, the dimming of thedisplay device 222 can alert a user viewing the display device 222 whenthe active area 223 of the display device will soon become blank.

Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user is provided with the opportunity to readily monitorinfusion pump operation by simply viewing the display 222 of thecontroller device 200. Such monitoring capabilities may provide comfortto a user who may have urgent questions about the current operation ofthe pump device 100 (e.g., the user may be unable to receive immediateanswers if wearing an infusion pump device having no user interfaceattached thereto).

Also, in these embodiments, there may be no need for the user to carryand operate a separate module to monitor the operation of the infusionpump device 100, thereby simplifying the monitoring process and reducingthe number of devices that must be carried by the user. If a need arisesin which the user desires to monitor the operation of the pump device100 or to adjust settings of the pump system 10 (e.g., to request abolus amount of medicine), the user can readily operate the userinterface 220 of the controller device 200 without the requirement oflocating and operating a separate monitoring module.

In other embodiments, the user interface 200 is not limited to thedisplay and buttons depicted in FIGS. 1-2. For example, in someembodiments, the user interface 220 may include only one button or mayinclude a greater numbers of buttons, such as two buttons three buttons,four buttons, five buttons, or more. In another example, the userinterface 220 of the controller device 200 may include a touch screen sothat a user may select buttons defined by the active area of the touchscreen display. Alternatively, the user interface 220 may comprise audioinputs or outputs so that a user can monitor the operation of the pumpdevice 100.

Referring to FIGS. 3-4, the infusion pump system 10 may be configured tobe portable and can be wearable and concealable. For example, a user canconveniently wear the infusion pump assembly 60 on the user's skin(e.g., skin adhesive) underneath the user's clothing or carry the pumpassembly 60 in the user's pocket (or other portable location) whilereceiving the medicine dispensed from the pump device 100. The pumpdevice 100 may be arranged in a compact manner so that the pump device100 has a reduced length. For example, in the circumstances in which themedicine cartridge 120 has a length of about 7 cm or less, about 6 cm toabout 7 cm, and about 6.4 cm in one embodiment, the overall length ofthe pump housing structure 110 (which contains medicine cartridge andthe drive system) can be about 10 cm or less, about 7 cm to about 9 cm,and about 8.3 cm in one embodiment. In such circumstances, thecontroller device 200 can be figured to mate with the pump housing 110so that, when removably attached to one another, the components define aportable infusion pump system that stores a relatively large quantity ofmedicine compared to the overall size of the unit. For example, in thisembodiment, the infusion pump assembly 60 (including the removablecontroller device 200 attached to the pump device 100 having the cap130) may have an overall length of about 11 cm or less, about 7 cm toabout 10 cm, and about 9.6 cm in one embodiment; an overall height ofabout 6 cm or less, about 2 cm to about 5 cm, and about 4.3 cm in oneembodiment; and an overall thickness of about 20 mm or less, about 8 mmto about 20 mm, and about 18.3 mm in one embodiment.

The pump system 10 is shown in FIGS. 3-4 is compact so that the user canwear the portable infusion pump system 10 (e.g., in the user's pocket,connected to a belt clip, adhered to the user's skin, or the like)without the need for carrying and operating a separate module. In suchembodiments, the cap device 130 of the pump device 100 may be configuredto mate with the infusion set 70. In general, the infusion set 70 istubing system that connects the infusion pump system 10 to the tissue orvasculature of the user (e.g., to deliver medicine into the tissue orvasculature under the user's skin). The infusion set 70 may include theflexible tube 72 that extends from the pump device 100 to thesubcutaneous cannula 76 retained by a skin adhesive patch 78 thatsecures the subcutaneous cannula 76 to the infusion site. The skinadhesive patch 78 can retain the infusion cannula 76 in fluidcommunication with the tissue or vasculature of the patient so that themedicine dispensed through the tube 72 passes through the cannula 76 andinto the user's body. The cap device 130 may provide fluid communicationbetween the output end 122 (FIG. 2) of the medicine cartridge 120 andthe tube 72 of the infusion set 70. For example, the tube 72 may bedirectly connected to the output port 139 (FIG. 2) of the cap device130. In another example, the infusion set 70 may include a connector(e.g., a Luer connector or the like) attached to the tube 72, and theconnector can then mate with the cap device 130 to provide the fluidcommunication to the tube 72. In these examples, the user can carry theportable infusion pump assembly 60 (e.g., in the user's pocket,connected to a belt clip, adhered to the user's skin, or the like) whilethe tube 72 extends to the location in which the skin is penetrated forinfusion. If the user desires to monitor the operation of the pumpdevice 100 or to adjust the settings of the infusion pump system 10, theuser can readily access the user interface 220 of the controller device200 without the need for carrying and operating a separate module.

Referring to FIG. 3, in some embodiments, the infusion pump assembly 60is pocket-sized so that the pump device 100 and controller device 200can be worn in the user's pocket 6 or in another portion of the user'sclothing. For example, the pump device 100 and the controller device 200can be attached together and form the assembly 60 that comfortably fitsinto a user's pocket 6. The user can carry the portable infusion pumpassembly 60 and use the tube 72 of the infusion set 70 to direct thedispensed medicine to the desired infusion site. In some circumstances,the user may desire to wear the pump assembly 60 in a more discretemanner. Accordingly, the user may pass the tube 72 from the pocket 6,under the user's clothing, and to the infusion site where the adhesivepatch 78 is positioned. As such, the pump system 10 can be used todeliver medicine to the tissues or vasculature of the user in aportable, concealable, and discrete manner. Furthermore, the monitoringdevice 50 can be worn on the user's skin while the pump assembly 60 iscarried by the user (e.g., in a pocket). As such, the monitoring device50 can communicate information indicative of the user's blood glucoselevel to the pump assembly 60 while the pump assembly 60 is used todeliver medicine through the infusion set 70. In this embodiment, themonitoring device 50 may be arranged on the user's skin at a locationthat is spaced apart from the infusion set 70.

Referring to FIG. 4, in other embodiments, the infusion pump assembly 60may be configured to adhere to the user's skin 7 directly at thelocation in which the skin is penetrated for medicine infusion. Forexample, a rear surface of the pump device 100 may include a skinadhesive patch so that the pump device 100 is physically adhered to theskin of the user at a particular location. In these embodiments, the capdevice 130 may have a configuration in which medicine passes directlyfrom the cap device 130 into an infusion cannula 76 that is penetratedinto the user's skin. In one example, the fluid output port 139 throughthe cap device 130 can include a curve or a 90° corner so that themedicine flow path extends longitudinally out of the medicine cartridgeand thereafter laterally toward the patient's skin 7. Again, if the userdesires to monitor the operation of the pump device 100 or to adjust thesettings of the infusion pump system 10, the user can readily access theuser interface 220 of the controller device 200 without the need forcarrying and operating a second, separate device. For example, the usermay look toward the pump device 100 to view the user interface 220 ofthe controller device 200 that is removably attached thereto. In anotherexample, the user can temporarily detach the controller device 200(while the pump device 100 remains adhered to the skin 7) so as to viewand interact with the user interface 220. Furthermore, the monitoringdevice 50 can be worn on the user's skin while the pump assembly 60 isworn on the user's skin in a different location from that where themonitoring device is worn. As such, the monitoring device 50 cancommunicate information indicative of the user's blood glucose level tothe pump assembly 60 while the pump assembly 60 is used to delivermedicine through the infusion set 70. In this embodiment, the monitoringdevice 50 may be arranged on the user's skin at a location that isspaced apart from the infusion set 70.

In the embodiments depicted in FIGS. 3-4, the monitoring device 50adheres to the user's skin 7 at the location in which the skin ispenetrated by the sensor shaft 56 (to detect blood glucose levels). Thesensor shaft 56 (refer to FIG. 1) penetrates the skin surface for thepurpose of exposing the tip portion of the sensor shaft 56 to the tissueor the vasculature of the user. The sensor shaft 56 can detectinformation indicative of the user's blood glucose level and transferthis information to a circuit that is connected to the communicationsdevice 54 located within the monitoring device 50. The communicationdevice 54 can be in wireless communication with the communication device247 (described in connection with FIG. 9) included in the controller 200of the pump assembly 60.

Referring now to FIGS. 5-8, in some embodiments, the infusion pumpassembly 60 can be operated such that the pump device 100 is adisposable, non-reusable component while the controller device 200 is areusable component. In these circumstances, the pump device 100 may beconfigured as a “one-time-use” device that is discarded after themedicine cartridge is emptied, expired, or otherwise exhausted. Thus, insome embodiments, the pump device 100 may be designed to have anexpected operational life of about 1 day to about 30 days, about 1 dayto about 20 days, about 1 to about 14 days, or about 1 day to about 7days—depending on the volume of medicine in the cartridge 120, thedispensation patterns that are selected for the individual user, andother factors. For example, in some embodiments, the medicine cartridge120 containing insulin may have an expected usage life about 7 daysafter the cartridge is removed from a refrigerated state and the septum121 (FIG. 2) is punctured. In some circumstances, the dispensationpattern selected by the user can cause the insulin to be emptied fromthe medicine cartridge 120 before the 7-day period. If the insulin isnot emptied from the medicine cartridge 120 after the 7-day period, theremaining insulin may become expired sometime thereafter. In eithercase, the pump device 100 and the medicine cartridge 120 therein can bediscarded after exhaustion of the medicine cartridge 120 (e.g., afterbeing emptied, expired, or otherwise not available for use).

The controller device 200, however, may be reused with subsequent newpump devices 100′ and new medicine cartridges 120′. As such, the controlcircuitry, the user interface components, and other components that mayhave relatively higher manufacturing costs can be reused over a longerperiod of time. For example, in some embodiments, the controller device200 may be designed to have an expected operational life of about 1 yearto about 7 years, about 2 years to about 6 years, or about 3 years toabout 5 years—depending on a number of factors including the usageconditions for the individual user. Accordingly, the user is permittedto reuse the controller device 200 (which may include complex orvaluable electronics) while disposing of the relatively low-cost pumpdevice 100 after each use. Such a pump system 10 can provide enhanceduser safety as a new pump device 100′ (and drive system therein) isemployed with each new fluid cartridge 120.

Referring to FIGS. 5-6, the pump device 100 can be readily removed fromthe controller device 200 when the medicine cartridge 120 is exhausted.As previously described, the medicine cartridge 120 is arranged in thecavity 116 (FIG. 2) of the pump housing 110 where it is retained by thecap device 130. In some embodiments, a portion of the pump housing 110can comprise a transparent or translucent material so that at least aportion of the medicine cartridge 120 is viewable therethrough. Forexample, the user may want to visually inspect the medicine cartridgewhen the plunger 125 is approaching the output end 122 of the medicinecartridge, thereby providing a visual indication that the medicinecartridge may be emptied in the near future. In this embodiment, thebarrel 111 of the pump housing 110 comprises a generally transparentpolymer material so that the user can view the medicine cartridge 120 todetermine if the plunger 125 is nearing the end of its travel length.

As shown in FIG. 5, the pump device 100 has been used to a point atwhich the medicine cartridge 120 is exhausted. The plunger 125 has beenadvanced, toward the left in FIG. 5, over a period of time so that allor most of the medicine has been dispensed from the cartridge 120. Insome embodiments, the controller device 200 may provide a visual oraudible alert when this occurs so as to remind the user that a newmedicine cartridge is needed. In addition or in the alternative, theuser may visually inspect the medicine cartridge 120 through the barrel111 of the pump housing 110 to determine if the medicine cartridge 120is almost empty. When the user determines that a new medicine cartridge120 should be employed, the pump device 100 can be readily separatedfrom the controller device 200 by actuating a release member 215. Inthis embodiment, the release member 215 is a latch on the controllerdevice 200 that is biased toward a locking position to engage the pumpdevice 100. The latch may be arranged to engage one or more features ona lateral side of the pump housing 110. As such, the user may actuatethe release member 215 by moving the release member 215 in a lateraldirection 216 (FIG. 5) away from the pump device 100 (e.g., by applyinga force with the user's finger).

As shown in FIG. 6, when the release member 215 is actuated and moved toa position away from the pump device 100, a segmented guide rail 114 a-bis free to slide longitudinally in a guide channel 214 a-b withoutinterference from the release member 215. Accordingly, the user can movethe pump device 100 in a longitudinal direction 217 away from thecontroller device 200. For example, the segmented guide rail 114 a-b mayslide along the guide channel 214 a-b, the extension 113 (FIG. 2) may bewithdrawn from the mating depression 213 (FIG. 6), and the electricalconnector 118 can be separated from the mating connector 218. In thesecircumstances, the pump device 100 is physically and electricallydisconnected from the controller device 200 while the pump deviceretains the exhausted medicine cartridge 120. It should be understoodthat, in other embodiments, other features or connector devices can beused to facilitate the side-by-side mounting arrangement. These otherfeatures or connector devices may include, for example, magneticattachment devices, mating tongues and grooves, or the like.

In some embodiments, the gasket 140 compressed between the pump device100 and the controller device 200 may comprise a resilient material. Insuch circumstances, the gasket 140 can provide a spring-action thaturges the pump device 100 to shift a small amount away from thecontroller device 200 when the release member 215 is moved to theunlocked position (e.g., moved in the lateral direction 216 in theembodiment shown in FIG. 5). Accordingly, in some embodiments, the pumpdevice 100 can automatically and sharply move a small distance (e.g.,about 0.5 mm to about 5 mm) away from the controller 200 when therelease member 215 is moved to the unlocked position. Such an automaticseparation provides a convenient start for the user to detach the pumpdevice 100 away from the controller device 200. Furthermore, thisautomatic separation caused by the spring-action of the gasket 140 canprovide a swift disconnect between the electrical connectors 118 and 218when the pump device 100 is being replaced.

Referring to FIGS. 7-8, the same controller device 200 can be reusedwith a new pump device 100′ having a new medicine cartridge 120′retained therein, and the previously used pump device 100 can bediscarded with the exhausted medicine cartridge 120. The new pump device100′ (FIG. 7) can have a similar appearance, form factor, and operationas the previously used pump device 100 (FIGS. 5-6), and thus the newpump device 100′ can be readily attached to the controller device 200for controlled dispensation of medicine from the new medicine cartridge120′. In some embodiments, the user may prepare the new pump device 100′for use with the controller device 200. For example, the user may insertthe new medicine cartridge 120′ in the cavity 116 of the new pump device100′ and then join the cap device 130 to the pump housing to retain thenew medicine cartridge 120′ therein (refer, for example, to FIG. 2).Although the tubing 72 of the infusion set 70 is not shown in FIG. 7, itshould be understood that the tubing 72 may be attached to the capdevice 130 prior to the cap device 130 being joined with the housing110. For example, a new infusion set 70 can be connected to the capdevice 130 so that the tubing 72 can be primed (e.g., a selectedfunction of the pump device 100 controlled by the controller 200) beforeattaching the infusion set patch to the user's skin. As shown in FIG. 7,the new medicine cartridge 120′ may be filled with medicine such thatthe plunger 125 is not viewable through the barrel 111. In someembodiments, the user can removably attach the pump device 100 to thecontroller 200 by moving the pump device 100 in a longitudinal direction219 toward the controller device 200 such that the segmented guide rail114 a-b engages and slides within the guide channel 214 a-b. When theelectrical connectors 118 and 218 mate with one another, the releasemember 215 can engage the segmented guide rails 114 a-b to retain thepump device 100 with the controller device 200.

As shown in FIG. 8, the previously used pump device 100 that wasseparated from the controller device (as described in connection withFIGS. 5-6) may be discarded after a single use. In these circumstances,the pump device 100 may be configured as a disposable “one-time-use”device that is discarded by the user after the medicine cartridge 120 isemptied, is expired, has ended its useful life, or is otherwiseexhausted. For example, the pump device 100 may be discarded into a bin30, which may include a trash bin or a bin specifically designated fordiscarded medical products. Thus, the user is permitted to dispose ofthe relatively low-cost pump device 100 after each use while reusing thecontroller device 200 (which may include complex or valuableelectronics) with subsequent new pumps 100′. Also, in somecircumstances, the infusion set 70 (not shown in FIG. 8, refer toFIG. 1) that was used with the pump device 100 may be removed from theuser and discarded into the bin 30 along with the pump device 100.Alternatively, the infusion set 70 can be disconnected from the previouspump device 100 and attached to the new pump device 100′. In thesecircumstances, the user may detach the infusion set cannula 76 and patch78 from the skin so as to “re-prime” the tubing with medicine from thenew pump device 100′ to remove air pockets from the tubing. Thereafter,the infusion set cannula 76 and patch 78 can be again secured to theuser's skin.

Referring now to FIG. 9, the controller device 200 (shown in an explodedview) houses a number of components that can be reused with a series ofsuccessive pump devices 100. In particular, the controller device 200includes control circuitry 240 arranged in the controller housing 210that is configured to communicate control signals to the drive system ofthe pump device 100. In this embodiment, the control circuitry 240includes a main processor board 242 that is in communication with apower supply board 244. The control circuitry 240 includes at least oneprocessor 243 that coordinates the electrical communication to and fromthe controller device 200 (e.g., communication between the controllerdevice 200 and the pump device 100). The processor 243 can be arrangedon the main processor board 242 along with a number of other electricalcomponents such as memory devices. It should be understood that,although the main processor board 242 is depicted as a printed circuitboard, the main processor board can have other forms, including multipleboards, a flexible circuit substrate, and other configurations thatpermit the processor 243 to operate. The control circuitry 240 can beprogrammable in that the user may provide one or more instructions toadjust a number of settings for the operation of the infusion pumpsystem 10. Such settings may be stored in the memory devices arranged inthe control circuitry 240. Furthermore, the control circuitry 240 mayinclude one or more dedicated memory devices that store executablesoftware instructions for the processor 243. The control circuitry 240may include other components, such as sensors, that are electricallyconnected to the main processor board 242. For example, in someembodiments, at least a portion of an occlusion detection system 250 canbe electrically connected to the main processor board 242 via a flexiblecircuit substrate or one or more wires, as described in more detailbelow in connection with FIGS. 17-19.

As previously described, the controller device 200 can be electricallyconnected with the pump device 100 via mating connectors 118 and 218 sothat the control circuitry 240 can communicate control signals to thepump device 100 and receive feedback signals from components housed inthe pump device 100. In this embodiment, the electrical connector 118(FIG. 2) on the pump device 100 is a z-axis connector, and the connector218 (FIG. 6) on the controller device 200 is adapted to mate therewith.The electrical connector 218 on the controller device 200 is incommunication with the control circuitry 240. As such, the processor 243can operate according to software instructions stored in the memorydevice so as to send control signals to the pump device 100 via theconnector 218.

Still referring to FIG. 9, the user interface 220 of the controllerdevice 200 can include input components, output components, or both thatare electrically connected to the control circuitry 240. For example, inthis embodiment, the user interface 220 includes a display device 222having an active area that outputs information to a user and fourbuttons 224 a-d that receive input from the user. Here, the display 222may be used to communicate a number of settings or menu options for theinfusion pump system 10. In this embodiment, the control circuitry 240may receive the input commands from the user's button selections andthereby cause the display device 222 to output a number of menus orprogram screens that show particular settings and data (e.g., reviewdata that shows the medicine dispensing rate, the total amount ofmedicine dispensed in a given time period, the amount of medicinescheduled to be dispensed at a particular time or date, the approximateamount of medicine remaining the cartridge 120, or the like). Aspreviously described, the controller circuit 240 can be programmable inthat the input commands from the button selections can cause thecontroller circuit 240 to change any one of a number of settings for theinfusion pump system 100.

Some embodiments of the control circuitry 240 may include a cableconnector (e.g., a USB connection port, another data cable port, or adata cable connection via the electrical connection 218) that isaccessible on an external portion of the controller housing 210. Assuch, a cable may be connected to the control circuitry 240 to uploaddata or program settings to the controller circuit or to download datafrom the control circuitry 240. For example, historical data of medicinedelivery can be downloaded from the control circuitry 240 (via the cableconnector) to a computer system of a physician or a user for purposes ofanalysis and program adjustments. Optionally, the data cable may alsoprovide recharging power.

Referring to FIGS. 9-10, the control circuitry 240 of the controllerdevice 200 may include a second power source 245 (FIG. 9) that canreceive electrical energy from a first power source 345 (FIG. 10) housedin the pump device 100. In this embodiment, the second power source 245is coupled to the power supply board 244 of the control circuitry 240.The hard-wired transmission of the electrical energy can occur throughthe previously described connectors 118 and 218. In such circumstances,the first power source 345 may include a high density battery that iscapable of providing a relatively large amount of electrical energy forits package size, while the second power source 245 may include a highcurrent-output battery that is capable discharging a brief current burstto power the drive system 300 of the pump device 100. Accordingly, thefirst battery 345 disposed in the pump device 100 can be used to deliverelectrical energy over time (e.g., “trickle charge”) to the secondbattery 245 when the controller device 200 is removably attached to thepump device 100. For example, the first battery 345 may comprise azinc-air cell battery. The zinc-air cell battery 345 may have a largevolumetric energy density compared to some other battery types. Also,the zinc-air cell battery may have a long storage life, especially inthose embodiments in which the battery is sealed (e.g., by a removableseal tab or the like) during storage and before activation.

The second battery 245 may include a high current-output device that ishoused inside the controller housing 210. The second battery 245 can becharged over a period of time by the first battery 345 and thenintermittently deliver high-current bursts to the drive system 300 overa brief moment of time. For example, the second battery 245 may comprisea lithium-polymer battery. The lithium polymer battery disposed in thecontroller device 200 may have an initial current output that is greaterthan the zinc-air cell battery disposed in the pump device 100, butzinc-air cell battery may have an energy density that is greater thanthe lithium polymer battery. In addition, the lithium-polymer battery245 is readily rechargeable, which permits the zinc-air battery 345disposed in the pump device 100 to provide electrical energy to thelithium-polymer battery 245 for purposes of recharging. In alternativeembodiments, it should be understood that the second power source 245may comprise a capacitor device capable of being recharged over time andintermittently discharging a current burst to activate the drive system105.

Accordingly, the infusion pump system 10 having two power sources 345and 245—one arranged in the pump device 100 and another arranged in thereusable controller device 200—permits a user to continually operate thecontroller device 200 without having to recharge a battery via awall-plug or other cable. Because the controller device 200 can bereusable with a number of pump devices 100 (e.g., attach the new pumpdevice 100′ after the previous pump device 100 is expended anddisposed), the second power source 245 in the controller device can berecharged over a period of time each time a new pump device 100 isconnected thereto. Such a configuration can be advantageous in thoseembodiments in which the pump device 100 is configured to be adisposable, one-time-use device that attaches to a reusable controllerdevice 200. For example, in those embodiments, the “disposable” pumpdevices 100 recharge the second power source 245 in the “reusable”controller device 200, thereby reducing or possibly eliminating the needfor separate recharging of the controller device 200 via a power cordplugged into a wall outlet.

Referring now to FIG. 10, the pump device 100 in this embodimentincludes the drive system 300 that is controlled by the removablecontroller device 200 (see FIG. 2). Accordingly, the drive system 300can accurately and incrementally dispense fluid from the pump device 100in a controlled manner. The drive system 300 may include a flexiblepiston rod 370 that is incrementally advanced toward the medicinecartridge 120 so as to dispense the medicine from the pump device 100.At least a portion of the drive system 300 is mounted, in thisembodiment, to the pump housing 110. Some embodiments of the drivesystem 300 may include a battery powered actuator (e.g., reversiblemotor 320 or the like) that actuates a gear system 330 to reset aratchet mechanism (e.g., including a ratchet wheel and pawl), a springdevice (not shown) that provides the driving force to incrementallyadvance the ratchet mechanism, and a drive wheel 360 that is rotated bythe ratchet mechanism to advance the flexible piston rod 370 toward themedicine cartridge 120. Connected to piston rod 370 is a pusher disc 375for moving the plunger 125 of the medicine cartridge 120.

Some embodiments of the drive system 300 can include a pressure sensor380 disposed between the plunger engagement device 375 and the plunger125 for determining the pressure within the fluid path (e.g., inside themedicine cartridge 120, the infusion set 70, and the like). For example,the fluid pressure in the medicine cartridge 120 can act upon theplunger 125, which in turn act upon the pressure sensor 380 arranged onthe dry side of the plunger 125. The pressure sensor 380 may comprise apressure transducer that is electrically connected (via one or morewires) to a gateway circuit 318 so that the sensor signals can becommunicated to the controller device 200 (e.g., via the electricalconnectors 118 and 218). As such, data from the pressure sensor 380 canbe received by the controller device 200 for use with an occlusiondetection module to determines if an occlusion exists in the medicineflow path.

The pressure within the medicine cartridge 120 may change over time andmay be characterized by a pressure curve such as the example depicted byFIG. 11A. As described above in connection with FIG. 10, activation ofthe drive system 300 results in the plunger 125 being incrementallyadvanced within the medicine cartridge 120. This advancement of theplunger 125 (FIG. 2) causes an initial increase in pressure inside thefluid path which, under normal conditions (e.g., when no occlusion ispresent), causes a controlled amount of fluid to be delivered out of thecartridge 120 and to the user. In some embodiments, the pressure sensor380 samples the pressure within the medicine cartridge 120 at a timeimmediately before the activation of the drive system 300. FIG. 11Arepresents nine such activations of the drive system 300 and thecoincident sampling of the pressure at the times labeled t₁-t₉. Theperiod from t₀-t₁ represents a time period when the drive system 300 isidle, the pressure within the medicine cartridge 120 is at anequilibrium, and no fluid is being dispensed from the pump assembly 60.

At time t₁ (just before the drive system 300 is activated), the pumpassembly 60 samples the fluid pressure (e.g., using the pressure sensor380) and communicates the detected pressure to the controller 200. Thetime between t₁ and t₂ represents an example of a generally normal pumpactivation cycle where the drive system 300 advances an incrementalamount, causing the plunger to move within the medicine cartridge 120and the pressure to increase within the fluid path. As fluid is expelledfrom the medicine cartridge 120, the pressure generally returns to theequilibrium value.

Still referring to FIG. 11A, at time t₂ (just before the drive system300 is activated again), the pressure sensor 380 samples the fluidpressure in the cartridge 120. In this example, the sensor dataindicates that the fluid pressure returned generally to the equilibriumlevel, thereby indicating that the incremental dosage from the previousactivation cycle was properly expelled from the cartridge 120 and intothe user's body.

In this pump activation cycle (i.e., the time between t₂ and t₃), theexpected amount of fluid is not expelled from the medicine cartridge 120due to an occlusion in the in the medicine flow path (e.g., a kink inthe infusion set tube 72, a blockage in the flow path, or the like). Attime t₃, the pressure is sampled and the pressure sensor 380 indicatesthat the pressure within the medicine cartridge 120 has not returned tothe equilibrium value (e.g., the pressure value depicted between timest₀ and t₁), but the detected pressure is also not greater than apredetermined pressure threshold level 410. On activation of the drivesystem 300 after t₃, the pressure increases due to the advancement ofthe plunger 125 to a level that is greater than the threshold level 410.After advancement of the plunger 125, the pressure falls due to partialdelivery of a dosage (e.g., some of the fluid is not delivered from themedicine cartridge 120 to the user due to a kink or partial blockage).For example, the detected pressure does not return to the level measuredat t₃ or the equilibrium value seen in the time interval between t₀ andt₁. At time t₅, the pressure sampled is above the threshold level 410for the first time in this example. In this embodiment, the controllerdevice 200 does not necessarily provide an alarm upon the first pressuredetection above the threshold pressure 410. Instead, in someembodiments, the controller device 200 may provide the alarm only aftera pattern of high pressure detections have occurred (e.g., so as toavoid instances of false alarms that can be a nuisance to the user).Continuing with this example in FIG. 11A, during the next foursubsequent activations of the drive system 300 (e.g., at t₆-t₉) thesampled pressure values are all above the threshold value 410. Asdescribed below in connection with FIG. 12, the controller device 200may use these consecutive high pressure measurements to determine thatan occlusion exists and alert the user (e.g., occlusion alarm).

Referring now to FIG. 11B, the pump assembly 60 can include the pressuresensor 380 that operates as a pressure switch to output “high” or “low”signals. For example, the pressure sensor 380 may not output a signalindicative of the actual pressure magnitude within the medicinecartridge 120, but instead may communicate either a “high” or a “low”signal depending on the detected pressure within the medicine cartridge120. When the pressure detected by the sensor 380 is greater than apredetermined value, the sensor 380 communicates the “high” signal. Whenthe pressure is lower than the predetermined value, the sensor 380communicates the “low” signal.

FIG. 11B depicts an exemplary output of the pressure swith in the casewhere the actual pressure magnitude within the medicine cartridge 120 isthe same as the pressure within the medicine cartridge 120 depicted inFIG. 11A. As in the example depicted by FIG. 11A, the pressure sensor380 is sampled immediately before the activation of the drive system300. In this example, the predetermined pressure threshold that marksthe boundary between high and low signals is the same pressure thresholdvalue 410 from FIG. 11A. When the pressure on the pressure sensor 380 isgreater than the pressure threshold value 410, the pressure sensor 380communicates a “high” signal. Conversely, when the pressure on thepressure sensing disc is less than or equal to the pressure thresholdvalue 410, the pressure sensor 380 communicates a “low” signal.

As seen in FIG. 11A, when the pressure sensor 380 is sampled at timest₁-t₄, the actual pressure magnitude in the medicine cartridge 120 isless than pressure threshold 410. Since the actual pressure magnitude isless than the pressure threshold 410, the pressure sensor 380 asconfigured in the example associated with FIG. 11B communicates a “low”signal to the controller device 200. At sampling time t₅, the pressureis greater than the threshold 410 causing the sensor 380 to output a“high” signal to the controller device 200. Subsequent sampling timest₆-t₉ coincide with pressures that are greater than the threshold 410,causing the sensor 380 to output a “high” signal. As previouslydescribed, the controller device 200 does not necessarily provide analarm upon the first “high” signal received from the pressure sensor380. In some circumstances, the controller device 200 may use a patternof consecutive “high” signals to determine that an occlusion exists. Asdescribed below, the sensitivity of the occlusion detection system maybe adjusted based upon changes to this pattern.

In some embodiments, the infusion pump system 10 is configured to alertthe user when an occlusion is detected so as to remedy the possibleinterruption of medicine delivery to the user. In certain situations, itmay be advantageous to detect a pattern of high pressure signals (e.g.,as illustrated in FIG. 11A or 11B) before communicating the alert theuser. For example, transient kinks can occur in the flexible tube 72,but these types kinks can self correct after a period of time. Duringthe period of this transient kink, the pressure within the medicinecartridge 120 can rise above a predetermined threshold (e.g., thepressure threshold level 410), but it is possible that the kink cansubsequently self correct after a short period of time (thereby allowingthe fluid to dispense to the user without any occlusion alarms thatrequire intervention from the user).

If occlusion alarms are activated too frequently when such transientkinks are present (especially when blood glucose levels fall within anormal range), the user may eventually choose to ignore or disable suchocclusion alarms (believing them to be false alarms). Such a pattern maylead the user to ignore authentic occlusion alarms and cause unsafeincreases in blood glucose levels. If occlusion alarms are activatedonly after too long of a period of high pressure detections, the usermay experience substantial increases in blood glucose levels due to theflow path occlusion. To provide a suitable balance to these factors, theinfusion pump system 10 can include an occlusion detection system withan adjustable sensitivity value. The sensitivity value can be used todecrease the likelihood of false alarms when blood glucose levels are inan acceptable range, while ensuring that the user is promptly alerted topossible occlusions when the blood glucose levels are dangerously high(e.g., at a time when insulin dispensation is an urgent concern).

In one embodiment, the adjustable sensitivity values can be indicativeof a time period (e.g., 2 minutes, 5 minutes, 10 minutes, or the like)to momentarily delay a user alarm after detecting a high pressuremagnitude in the fluid path. In these examples, the controller device200 can identify a high pressure detection indicative of an occlusionand wait a predetermined period of time before alerting the user of thiscondition. If the occlusion is corrected (either with or without userintervention) within the period of time, the occlusion alarm can becancelled. In these examples, if an occlusion is corrected within aperiod of time, the user may never be alerted that the transientocclusion existed, thus minimizing the amount of false alarmscommunicated to the user.

In other embodiments, the sensitivity value can include a number (e.g.,1, 2, 3, 4, 5, 6, or the like) indicating the quantity of times that thepressure sensor 380 consecutively outputs a high pressure signal (e.g.,above a pressure threshold value 410) before alerting the user. Forexample, the controller device 200 may be programmed with a sensitivityvalue of “5”, indicating that five consecutive pressure samples must begreater than the pressure threshold level 410 before an occlusion isdetermined to exist. In the examples depicted in FIGS. 11A-11B, thefirst occurrence of a pressure sample that is greater than the pressurethreshold 410 occurs at time t₅. In this case, if the sensitivity valueis set to “5”, the user will not be alerted to the occlusion until afterthe sample taken at time t₉. If, between sampling times t₅ and t₉, theocclusion is corrected (either with or without user intervention), theocclusion alert will not be communicated to the user, thereby minimizingthe amount of false alarms received by the user.

Referring now to FIG. 12, some embodiments of a process 400 foroutputting an occlusion alarm to a user can include a number ofoperations performed by the controller device 200. In operation 405, thecontroller device 200 is in a standby mode in which the pump assembly 60is awaiting the next activation cycle of the drive system 300. Inoperation 408, the pressure fluid is detected. For example, aspreviously described, the pump assembly 60 may include the pressuresensor 380 (FIG. 10) that outputs a sensor signal indicative of thepressure magnitude in the fluid path to the controller device 200. Inoperation 410, the drive system 300 is activated. For example, thecontroller device 200 may activate the drive system 300 to deliver anincremental dosage of medicine in accordance with the basal deliveryprogram. As previously described, activation of the drive system 300causes the plunger 125 to advance within the medicine cartridge 120(FIG. 2). Advancing the plunger 125 causes the pressure inside the fluidpath (e.g., the medicine cartridge 120, the infusion set 70, and thelike) to increase thus expelling fluid out the output port 139, throughthe flexible tube 72, out the cannula 76, and into the user through theskin. As the fluid is expelled, the pressure within the medicinecartridge returns to an equilibrium pressure, at which point fluid is nolonger delivered from the medicine cartridge 120. In the case of anocclusion (e.g., a kink in the flexible tube 72, a blockage in thecannula 76, or the like) the advancing plunger 125 may cause an increasein the fluid pressure because the pressure created within the medicinecartridge 120 during the advancing of the plunger 125 may not be fullyrelieved by the incremental dispensation of fluid to the user.

In operation 415, the pressure value obtained during operation 408 iscompared to a predetermined threshold value. (It should be understoodthat operation 415 may occur before, after, or contemporaneously withthe operation 410 so long as it occurs after operation 408.) If thesampled pressure is less than or equal to the threshold pressure,operation 420 is performed and a counter value is reset to zero. Thecounter value may be, for example, a numerical value stored in memory ofthe controller device 200. Thereafter, the process 400 may return tooperation 405 in which the controller 200 returns to the standby mode.

If operation 415 indicates that the sampled pressure is greater than thepressure threshold, operation 425 is performed to incrementally increasethe counter. After the counter is incremented during operation 425,operation 430 is performed, comparing the value stored in the counter toa predetermined alarm sensitivity K value. If the counter is less thanthe sensitivity K value, the process 400 returns to operation 405. Ifthe counter is greater than or equal to the sensitivity K value,operation 435 is performed and the controller device 200 outputs anocclusion alarm to the user. The occlusion alarm may include a messageon the display 222 (refer, for example, to FIG. 1), an audible alert, oranother alert to communicate with the user.

As previously described, the infusion pump system 10 can be configuredto adjust sensitivity value based (at least in part) on the informationreceived from the glucose monitoring device. In some embodiments, thesensitivity K value may be selected so that the occlusion alarm isprovided to the user in a timely manner while reducing the likelihood offalse alarms. If a user's blood glucose level is high, the risk posed byan occlusion may be significant. As such, the sensitivity of theocclusion detection system may be increased during periods when themonitoring device 50 indicates that the user's blood glucose level iswithin a designated “high” range (refer, for example, to FIG. 13).However, if a user's blood glucose level falls within a “normal” range,the problems associated with false alarms (e.g., false alarms may be anuisance for the user) may be greater than the need for rapid orimmediate occlusion alarms. As such, the sensitivity of the occlusiondetection system may be returned to a standard setting (e.g., moderatesensitivity) when the monitoring device 50 indicates that the user'sblood glucose level is within a “normal” range.

Accordingly, the pump system 10 can be configured to adjust thesensitivity of the occlusion detection system based (at least in part)on the detected blood glucose level or another blood characteristic.Such adjustments can be used to decrease the likelihood of false alarmswhen blood glucose levels are in an acceptable range, while ensuringthat the user is promptly alerted to possible occlusions when the bloodglucose levels are high and insulin dispensation is an urgent concern.

Referring to FIG. 13, some embodiments of a process 500 can be utilizedto adjust the sensitivity of an occlusion detection system based (atleast in part) on information indicative of a blood glucose level. Theprocess 500 may include a number of operations that are performed by thecontroller device 200 of the pump system 10. In operation 505, thecontroller device 200 may receive glucose data from, for example, themonitoring device 50. As previously described, the monitoring device 50may communicate wirelessly with the controller device 200. In operation510, the controller device 200 can compare the glucose level obtainedduring operation 505 to a predetermined threshold value. If the user'ssensed glucose level is not greater than a threshold value (e.g., aglucose level representing an upper limit of a normal range), theprocess 500 can return to operation 505 and stands by for subsequentglucose monitoring data.

If the glucose level is greater than the threshold value, operation 515is performed and the sensitivity of the occlusion detection system isincreased. In some embodiments, the controller device 200 increases thesensitivity of the occlusion detection system by decreasing thesensitivity K value (described in connection with FIG. 12). In oneexample, the sensitivity K value can be decreased from “5” to “3”,meaning that only three consecutive high pressure detections arerequired to activate the occlusion alarm (instead of five). As such, theuser is more promptly alerted to possible occlusions when the bloodglucose levels are higher than the normal range.

In some circumstances, the pump system 10 may indicate to the user thatthe detected glucose level (e.g., as detected by the glucose monitoringdevice 50) is at an elevated state. In operation 520, the controller 200can provide an alert to the user indicating that the user's glucoselevel is elevated (refer, for example, to FIG. 1). Also, in someembodiments, the pump system 10 may indicate to the user that thesensitivity of the occlusion detection system was adjusted. For example,in operation 525, the controller device 200 can provide an alert to theuser indicating that the sensitivity of the occlusion detection systemhas been increased. After completion of operation 525, process 500 canreturn to operation 505 and receive additional information that isindicative of the user's blood glucose level. It should be understoodthat, after the user's blood glucose levels have returned to a normalrange, the sensitivity of the occlusion detection system may likewisereturn to a previous value condition (in this example, the sensitivity Kvalue can be returned to “5”, meaning that five or more consecutive highpressure detections are required to activate the occlusion alarm).

In some embodiments, it may be advantageous for the pump system 10 tomodify the sensitivity of an occlusion detection system based (at leastin part) on something other than the measured glucose level of thepatient (refer to FIG. 13). For example, a user's glucose level may bewithin a normal range but increasing at a high rate, which may indicatethat the user's glucose level could soon be above an upper limit of anormal range. In some circumstances, the pump system 10 can adjust thesensitivity of the occlusion detection system in response to a high rateof change in the detected glucose level. As such, the system can respondto a significant rate of increase in the blood glucose level withoutnecessarily waiting for the blood glucose level to rise to a high value.In one example, a current glucose measurement indicates that a user'sblood glucose level is 185 mg/dL and the controller 200 is programmedwith a normal range of 80-200 mg/dL. If a previous glucose measurement(e.g., taken 10 minutes before the current measurement) may haveindicated a blood glucose level of 165 mg/dL for the user. In this case,the user's blood glucose level has risen at a rate of 20 mg/dL in 10minutes. At this rate of increase, the blood glucose level could soon beabove the upper limit of the normal range, representing a dangerouscondition for the user that could be exacerbated by an occlusion in thefluid delivery path of the pump system 100. In this example, it may beadvantageous for the controller device 200 to recognize the high rate atwhich the blood glucose level is rising and increase the sensitivity ofthe occlusion detection system for the safety of the user.

In one example, referring to FIG. 14, a process 600 can be utilized toadjust the sensitivity of the occlusion detection system. A number ofoperations in the process 600 can be performed by the controller device200. For example, in operation 605, the controller device 200 canreceive glucose data from the monitoring device 50 so as to determinethe rate at which the glucose level is rising (e.g., by comparing thecurrent value with one or more previous values). In operation 610, thecontroller device 200 can compare the rate at which the measured glucoselevel is rising to a predetermined threshold rate value. In the examplein which the measured glucose level is not rising at a rate that isgreater than the threshold rate value, the process 600 can return tooperation 605 and await further glucose data. If the measured glucoselevel, as determined by the controller 200, is rising at a rate that isgreater than the threshold rate value, operation 615 is performed toincrease the sensitivity of the occlusion detection system. In someembodiments, operation 615 can be performed by the controller device 200to increase the sensitivity of the occlusion detection system bydecreasing the alarm sensitivity K value described in connection withFIG. 12. In one example, the sensitivity K value is decreased from “5”to “3”, meaning that only three consecutive high pressure detections arerequired to activate the occlusion alarm (instead of five).

In these embodiments, the pump system 10 may indicate to the user (e.g.,via the display device 222, an audible tone, or the like) that theuser's blood glucose level is changing at a high rate and/or that thesensitivity of the occlusion detection system was adjusted. For example,in operation 620, the controller device 200 can provide an alert to theuser indicating that the user's glucose level is rising at an elevatedrate. In operation 625, the controller device 200 can provide an alertto the user indicating that the sensitivity of the occlusion detectionsystem has been increased (refer, for example, to FIG. 1). It should beunderstood that, after the user's blood glucose level ceases rising atan elevated rate and is maintained within a normal range, thesensitivity of the occlusion detection system may return to a previousvalue condition (in this example, the sensitivity K value can bereturned to “5”, meaning that five or more consecutive high pressuredetections are required to activate the occlusion alarm).

In some embodiments, the sensitivity of the occlusion detection systemcan be adjusted if the user's blood glucose level falls below a normalrange. For example, if a user's blood glucose level falls below a safelevel, the need to consume food and raise the blood glucose level may bemore urgent than with receiving more insulin and/or responding topossible occlusions alarms. In such circumstances, the sensitivity ofthe occlusion detection may be decreased to temporarily reduce theinstances of possible false alarms, which may become a nuisance anddistract the user from increasing the blood glucose level.

Referring to FIG. 15, a process 800 can be utilized to decrease thesensitivity of an occlusion detection system based (at least in part) onthe glucose information transmitted from the monitoring device. Theprocess 800 may include a number of operations that are performed by thecontroller device 200 of the pump system 10. In operation 805, thecontroller 200 may receive glucose data from the monitoring device 50via, for example, wireless communication. In operation 810, thecontroller 200 may compare the measured glucose level obtained duringoperation 805 to a predetermined minimum threshold value (e.g., aglucose level representing a lower limit of a normal glucose range). Ifthe measured glucose level is not less than the threshold value, theprocess 800 returns to operation 805 and stands by for subsequentglucose monitoring data. If the measured glucose level is less than thethreshold value, operation 815 is performed and the controller device200 may decrease the sensitivity of the occlusion detection system(e.g., to reduce the occurrence of false alarms, nuisance alarms, or thelike). In some embodiments, the controller device 200 decreases thesensitivity of the occlusion detection system by increasing the alarmsensitivity K value (described in connection with FIG. 12). In oneexample, the sensitivity K value is increased from “5” to “7”, meaningthat seven consecutive high pressure detections are required to activatethe occlusion alarm (instead of five), before outputting an alarm to theuser.

Similar to previously described embodiments, the pump system 10 mayindicate to the user that the sensitivity of the occlusion detectionsystem was adjusted. For example, in operation 820, the controllerdevice 200 can provide an alert to the user indicating that thesensitivity of the occlusion detection system has been decreased (e.g.,via the display device 222, an audible tone, or the like). Thecontroller device 200 may contemporaneously alert the user of thedetected glucose level that is lower than the normal range. Aftercompletion of operation 820, process 800 can return to operation 805 andstands by for subsequent glucose data. It should be understood that,after the user's blood glucose level returns to the normal range, thesensitivity of the occlusion detection system may likewise return to aprevious value condition (in this example, the sensitivity K value canbe returned to “5”, meaning that five or more consecutive high pressuredetections are required to activate the occlusion alarm).

In some embodiments, it may be advantageous for the pump system 10 tomodify the sensitivity of an occlusion detection system based (at leastin part) on a significant rate of decrease of the user's blood glucoselevel. For example, a user's glucose level may be within a normal range,but decreasing at a high rate, indicating that the user's glucose levelcould soon fall below a lower limit of a normal range. In someembodiments, the pump system 10 can adjust the sensitivity of theocclusion detection system in response to the negative rate of change inthe detected glucose level. As such, the system can respond to asignificant rate of decrease in the blood glucose level withoutnecessarily waiting for the blood glucose level to fall below the normalrange. In this example, the controller device 200 can recognize thesignificant rate at which the blood glucose level is falling anddecrease the sensitivity of the occlusion detection system so as totemporarily reduce the instances of possible false alarms, which maybecome a nuisance and distract the user from maintaining normal glucoselevels.

Referring to FIG. 16, in one example, a process 900 can be utilized toadjust the sensitivity of an occlusion detection system. A number ofoperations in the process 900 can be performed by the controller device200. For example, in operation 905, the controller device 200 canreceive glucose data from, for example, the monitoring device 50 so asto determine the rate at which the glucose level is falling (e.g., bycomparing the recent value to one or more previous values). In operation910, the controller device 200 can compare the rate at which themeasured glucose level is falling to a predetermined threshold ratevalue. If the measured glucose level is not falling at a rate that isgreater than the threshold rate value, the process 900 returns tooperation 905 and stands by for subsequent glucose monitoring data. Ifthe measured glucose level is falling at a rate greater than thethreshold rate value, operation 915 is performed to decrease thesensitivity of the occlusion detection system. In some embodiments, thesensitivity of the occlusion detection system is decreased by thecontroller 200, in operation 915, by increasing the alarm sensitivity Kvalue (as described in connection with FIG. 12). In one example, thesensitivity K value is increased from “5” to “7”, meaning that sevenconsecutive high detections are required to activate the occlusion alarm(instead of five).

Similar to previously described embodiments, the pump system 10 mayindicate to the user (e.g., via the display device 222, an audible tone,or the like) that the sensitivity of the occlusion detection system wasadjusted. For example, in operation 920, the controller device 200 canprovide an alert to the user indicating that the sensitivity of theocclusion detection system has been decreased. The controller device 200may also alert the user of the detected glucose level is decreasing at asignificant rate. After completion of operation 920, process 900 canreturn to operation 905 and stands by for subsequent glucose data. Itshould be understood that, after the user's blood glucose level is nolonger decreasing at a significant rate and is maintained within thenormal range, the sensitivity of the occlusion detection system mayreturn to a previous value condition (in this example, the sensitivity Kvalue can be returned to “5”, meaning that five or more consecutive highpressure detections are required to activate the occlusion alarm).

In alternate embodiments, the process for adjusting the sensitivity ofan occlusion detection system can include multiple threshold values (orrate values) that can cause stepped adjustments to the sensitivity ofthe occlusion detection system. For example, a first threshold value canbe employed to cause adjustment of the sensitivity K value (refer toFIG. 12) from “5” to “4” when the detected blood glucose level reachespast the first threshold value, while a second threshold value can beemployed to cause adjustment of the sensitivity K value from “4” to “3”when the detected blood glucose level reaches past the second thresholdvalue. Additional threshold values may be employed to further adjust thesensitivity K value. In other embodiments, the baseline sensitivity Kvalue can be selected to be a value other than five (e.g., “2”, “3”,“4”, “6”, “7”, or the like).

Referring now to FIGS. 17-19, the occlusion detection system is notlimited to embodiments that employ a pressure transducer or a pressureswitch. For example, the infusion pump system 10 can be equipped with anoptical occlusion detection system 250. In some embodiments, thecontroller device 200 may include the optical sensor detection system250 to detect the amount of light reflected from a portion of the capdevice 130 or another portion of the medicine flow path. The opticaldetection system 250 can detect changes in the amount of light reflectedfrom the cap device 130 in response to an occlusion that causes anincrease in the fluid pressure in the medicine flow path. For example,as described below in connection with FIGS. 18-19, the optical sensorsystem 250 may operate using the principle of total internal reflection.

Referring to FIG. 17, although the optical sensor system 250 operates todetect changes in the flow path from the pump device 100 (e.g., throughthe cap device 130), the optical sensor system 250 may include a numberof components that are housed in the controller device 200. For example,a light emitter and light sensor may be arranged on a sensor circuit 252that is housed by the controller device 200, thereby permitting thesecomponents to be reused along with the controller device (while therelatively low cost components in the pump device 100 are discardedafter the “one time use” of the pump device 100). The sensor circuit 252can be arranged so that the cap device 130 is aligned with the lightemitter and the light sensor (described below) when the pump device 100is attached to the controller device 200. It should be understood thatthe pump housing 110 and the controller housing 210 have been removedfrom FIG. 17 for purposes of showing the relative position of the sensorcircuit 252 and the cap device 130 (attached to the pump housing 110 asshown in FIG. 2).

The sensor circuit 252 can be connected to the control circuitry 240 ofthe controller device 200 (see FIG. 9 for the location of the controlcircuitry 240 within the controller 200) via a flexible circuitsubstrate or one or more wires. In this embodiment, the sensor circuit252 connects with the main processor board 242 via a flexible circuitsubstrate. The control circuitry 240 can receive sensor signals andemploy detection software stored in one or more memory devices todetermine if an occlusion exists. As described in more detail below, ifthe sensor signals from optical sensor system 250 indicate that anocclusion exists in the fluid flow path, the controller device 200 cantrigger an alert to inform the user. The alert may include a visual oraudible alarm communicated via the user interface 220 of the controllerdevice 200.

Referring now to FIGS. 18-19, in some embodiments, the controller device200 can determine whether an occlusion exists using sensor signalscommunicated to the control circuitry 240 of the controller device 200.In particular, the control circuitry 240 can be used to activate thelight emitter 253 and the light sensor 258 at selected times to monitorthe fluid pressure in the flow path. For example, the control circuitry240 can activate the light emitter 253 and the light sensor 258 one ormore times during activation of the drive system 300 (FIG. 10) to forcemedicine from the medicine cartridge 120, before the drive system 300 isactivated, or after the drive system 300 is activated. The controlcircuitry 240 can receive detector signals from the light sensor 258 andthereafter process the data to determine if an alert should be triggeredto notify the user of an occlusion.

Referring to FIG. 18, in this embodiment, the control circuitry 240 canactivate the sensor circuit 252 one or more times shortly after thedrive system 300 (FIGS. 10) is activated (e.g., while the drive system300 is operating) to force medicine from the medicine cartridge 120.When the sensor circuit 252 is activated, the light emitter 253 emitslight toward the internal light transmissive member 254, passing througha first curved surface 255. The light from the light emitter 253 can bein the form of an infrared light beam. As shown in FIG. 18, when nosubstantial occlusion exists in the flow path, the fluid pressure of themedicine passing through the cap device 130 may be below a selectedthreshold value. In these circumstances, the flexible membrane 264 thatis adjacent to the fluid channel 260 is not substantially deformed(e.g., the membrane 264 does not flex downwardly into the air cavity 265to abut the internal light transmissive member 254). The light from thelight emitter 253 can be reflected at the interface where the internallight transmissive member 254 meets the air cavity 265. In someembodiments, this light reflection may occur due to total internalreflection at the interface. This reflected light continues through theinternal light transmissive member 254 toward a second curved surface257. The second curved surface 257 may operate as a focusing lens thatdirects the infrared light toward the light sensor 258. As previouslydescribed, in some embodiments, the light sensor 258 may comprise aninfrared photo detector that is capable of converting the receipt ofinfrared light into electrical signals. These electrical signals fromthe light sensor 258 can be transmitted via the sensor circuit 252 tothe control circuitry 240. The control circuitry 240 receives thesignals from the light sensor 258 and uses this data, along withadditional information such as the alarm sensitivity K value describedin connection with FIG. 12, to determine if an occlusion alarm should beprovided to the user. In the example depicted in FIG. 18, the controlcircuitry 240 receives signals that indicate the pressure in the fluidchannel 260 is within the normal operating range.

Referring to FIG. 19, the control circuitry 240 can again activate thesensor circuit 252 one or more times shortly before the drive system 300(FIGS. 18-20) is activated to force medicine from the medicine cartridge120. When the sensor circuit 252 is activated, the light emitter 253emits light toward the light transmissive member 254. When an occlusionexists in the flow path, the fluid pressure of the medicine passingthrough the cap device 130 may rise to a level above the thresholdvalue. For example, when one or more earlier drive cycles were attemptedwhile the infusion set tubing 72 is clogged or kinked, the fluidpressure upstream of the occlusion (e.g., in the medicine cartridge 120and in the cap device 130) can be increased. In these circumstances, theflexible membrane 264 that is adjacent to the fluid channel 260 may besubstantially deformed (e.g., the membrane 264 will flex downwardly intothe air cavity 265 to abut the light transmissive member 254.) In theexample depicted by FIG. 19, the interface where the light transmissivemember 254 meets the flexible membrane 264 provides different opticalresults than the previously described interface (FIG. 18) where thelight transmissive member 254 meets the air cavity. In particular, theamount of light from the light emitter 253 that is internally reflectedat the interface where the light transmissive member 254 meets theflexible membrane 264 is measurably less (as illustrated by the dottedlines in FIG. 19).

Still referring to FIG. 19, the light that is not internally reflectedat this interface may pass into the medium of flexible membrane 264 andperhaps into the fluid channel 260. For example, the refractive index ofthe material of the flexible membrane 264 can be substantially similarto that of the material of the light transmissive member 254. As aresult, the light being transmitted through the light transmissivemember 254 can pass into the flexible membrane 264 when the membrane 264flexes into the air cavity 265 and contacts the flat surface of thelight transmissive member 254. The light from the light emitter 253 doesnot undergo total internal reflection at the portion where the flexiblemembrane 264 interfaces with light transmissive member 254, therebyresulting in reduced amount of light received by the light sensor 258.If any portion of the light is internally reflected, this reducedportion of reflected light continues through the light transmissivemember 254 toward a second curved surface 257 and then toward the lightsensor 258. Because the amount of light that is internally reflected inthe light transmissive member 254 is measurably less, the light sensor258 can produce detection signals that are different from thosedescribed in connection with FIG. 18.

Referring again to FIGS. 18-19, the detection signals from the lightsensor 258 can be transmitted via the sensor circuit 252 to the controlcircuitry 240. The control circuitry 240 receives the signals from thelight sensor 258 and uses this data, at least in part, to determine ifan occlusion alert should be provided to the user. In the exampledepicted in FIG. 19, these detection signals may indicate that the fluidpressure in the cap device 130 has risen above the threshold level dueto a downstream occlusion.

As previously described, the control circuitry 240 receives the signalsfrom the light sensor 258 and uses this data to determine if anocclusion alert should be provided to the user. For example, the controlcircuitry 240 may include a detection software module and an alerttrigger module stored in one or more memory devices (e.g., on the mainprocessor board 242).

The detection software module may include instructions to use the datasignals from the light sensor 258 as input data for a comparativealgorithm that determines if an occlusion exists and whether or not toalert the user if an occlusion exists. The comparative algorithm can,for example, compare the data values from the light sensor 258 to aninitial value recorded when the pump device 100 was initially activatedwith no occlusions in the flow path. Alternatively, the comparativealgorithm can, for example, average the data values from the lightsensor 258 recorded over a predetermined period of time (e.g., 2minutes, 5 minutes, 10 minutes, 30 minutes, or the like) or over apredetermined number of pump drive cycles (e.g., the last 3 drivecycles, the last 5 drive cycles, the last 10 drive cycles). Then, thisaverage value can be compare to an initial value recorded when the pumpdevice 100 was initially activated with no occlusions in the flow path.These comparative algorithms can be used to reduce the instances of“false alarms” that are provided to the user, and in some cases, can beused to reduce error created by noise in the sensor system.Additionally, or in the alternative, the comparative algorithms canutilize a sensitivity value such as the alarm sensitivity K valuedescribed below in connection with FIG. 20. It should be understood fromthe description herein that, in other embodiments, the detectionsoftware module may employ other algorithms to process the data andthereby determine if an occlusion exists.

If the detection software module indicates than an occlusion exists, thecontrol circuitry 240 can activate the alarm trigger module to alert theuser. The alarm trigger module can be used to activate the userinterface 220 (FIG. 1) to communicate one or more alarms. For example,the alarm trigger module of the control circuitry may be used toactivate an audible alarm, a visual alarm (e.g., on the display device222 as shown in FIG. 1), or a combination thereof. In some embodiments,the alarm trigger module is configured to provide a set of escalatingalarms. For example, the first stage of the alarm may include a lowintensity audible alert followed by a textual alarm on the displaydevice. If the user does not respond after a predetermined period oftime (e.g., 10 seconds, 30 seconds, or the like) and/or a predeterminednumber of pump system 300 activation cycles (e.g., 3, 5, 6, or thelike), the alarm trigger module may then provide a high intensityaudible alert (e.g., louder alert) in combination with a visual alarmhaving image effects on the display device (e.g., a blinking screen,alternating images, or the like). The alarm trigger module may includefurther stages of alarm if the user does not respond after apredetermined period of time. When the user is alerted to the occlusionin the flow path, the user can inspect the infusion set tubing 72 andthe cannula 76 to determine if there is a repairable kink. If theocclusion is substantial, the user can suspend the operation of theinfusion pump system 10 and replace the infusion set 70 with a newinfusion set 70.

Referring now to FIG. 20, some embodiments of a process 1000 forproviding an occlusion alarm to a user can include a number ofoperations performed by the controller device 200 of the pump assembly60. In operation 1005, the controller device 200 is in a standby mode inwhich the pump assembly is awaiting the next activation cycle of thedrive system 300. In operation 1008, the occlusion detection system isactivated and an optical detection signal indicative of the fluidpressure status is received. For example, as previously described inconnection with FIGS. 17-19, the pump system 10 can activate an opticalocclusion detection system, such as the optical sensor system 250, tosample the fluid pressure state (e.g., to determine if the pressurewithin the fluid path is higher than a predetermined threshold). In oneexample, the optical sensor system 250 can output a “low” signal if themagnitude of the pressure within the fluid path is less than or equal toa predetermined threshold (e.g., the fluid pressure does not causesufficient flexing of membrane 264 as shown in FIG. 18), and can outputa “high” signal if the pressure magnitude is greater than thepredetermined threshold (e.g., the fluid pressure causes the flexiblemembrane 264 to flex as described in FIG. 19). In operation 1010, thedrive system 300 is activated. For example, the controller device 200may activate the drive system 300 to deliver an incremental dosage ofmedicine in accordance with the basal delivery program, the bolusdelivery program, or the like. As previously described, the activationof the drive system 300 causes the plunger 125 to advance within thecartridge 120 (FIG. 2). Advancing the plunger 125 can cause the pressureinside the medicine cartridge 120 to at least temporarily increase, thusexpelling fluid out the output port 139, through the flexible tube 72,out the cannula 76 and into the user through the skin. As the fluid isexpelled, the pressure within the medicine cartridge returns to anequilibrium pressure, at which point fluid no longer is delivered fromthe medicine cartridge 120. In the event of an occlusion (e.g., a kinkin the flexible tube 72, a blockage in the cannula 76, or the like) theadvancing plunger 125 can cause an increase in the fluid pressure, butthe expected amount of fluid is not necessarily expelled from thecartridge 120. In these circumstances, the pressure developed within themedicine cartridge 120 during the advancement of the plunger 125 may notbe fully relieved.

In operation 1015, the sensor signal received during operation 1008 isevaluated by the controller device 200. (It should be understood thatthe operation 1015 can be performed before, after, or contemporaneouslywith operation 1010 so long as it performed after operation 1008.) Ifthe signal provided by the occlusion detection system is a low signal,operation 1020 can be performed so that the controller device 200 resetsa counter value to zero. The counter value may be, for example, anumerical value stored in the memory of the controller device 200.Thereafter, the process 1000 returns to operation 1005 to stand by forsubsequent activations of the drive system 300. If the sensor signalprovided by the occlusion detection system is a “high” signal, operation1025 is performed so that the controller device 200 incrementallyincreases the counter value by one unit.

Still referring to FIG. 20, after operation 1025 is performed (so thatthe counter value was incremented by one unit), the process 1000 cancontinue to operation 1030 in which the controller device 200 cancompare the counter value to a predetermined alarm sensitivity K value.If the counter is less than the sensitivity K value, the process 1000returns to operation 1005 in which the controller device returns to astandby mode. If the counter is greater than or equal to the sensitivityK value, operation 1035 is performed and the controller device 200outputs an occlusion alarm to the user.

In some embodiments, the sensitivity K value may be selected so that theocclusion alarm is provided to the user in a timely manner whilereducing the likelihood of false alarms (e.g., from transient kinks inthe tubing 72 or the like). For example, the sensitivity K value may beselected to be “5” so that the occlusion alarm is output in the event offive or more consecutive high pressure detections. For example, if auser's blood glucose level is high, the risk posed by an occlusion maybe significant. As such, the sensitivity of the occlusion detectionsystem may be increased during periods when the monitoring device 50indicates that the user's blood glucose level is within a designated“high” range (FIG. 1). However, if a user's blood glucose level fallswithin a “normal” range, the problems associated with false alarms(e.g., false alarms may be a nuisance for the user) may be greater thanthe need for rapid or immediate occlusion alarms. In thesecircumstances, the sensitivity of the occlusion detection system may bereturned to a standard setting (e.g., moderate sensitivity) when themonitoring device 50 indicates that the user's blood glucose level iswithin a “normal” range. Such adjustments can be used to decrease thelikelihood of false alarms when blood glucose levels are in anacceptable range, while ensuring that the user is promptly alerted topossible occlusions when the blood glucose levels are high and insulindispensation is an urgent concern.

Referring to FIG. 21, some embodiments of a process 1100 can be utilizedto adjust the sensitivity of an occlusion detection system (e.g., theoptical detection system 250) based (at least in part) on informationindicative of a user's blood glucose level. The process 1100 may includea number of operations that are performed by the controller device 200of the pump system 10. In operation 1105, the controller device 200 mayreceive glucose data from, for example, the glucose monitoring device50. As previously described, the monitoring device 50 may communicatewirelessly with the controller device 200. In operation 1110, thecontroller device 200 can compare the glucose level obtained duringoperation 1105 to a predetermined threshold value (e.g., a glucose levelrepresenting an upper limit of a normal glucose range). If the glucoselevel is not greater than the threshold value, the process 1100 canreturn to operation 1105 and stands by for subsequent glucose monitoringdata. If the glucose level is greater than the threshold value,operation 1115 is performed and the sensitivity of the occlusiondetection system is increased. In some embodiments, the controllerdevice 200 increases the sensitivity of the occlusion detection systemin operation 115 by decreasing the alarm sensitivity K value (describedin connection with FIG. 12). In one example, the alarm sensitivity Kvalue is decreased from “5” to “3”, meaning that only three consecutivehigh pressure detections are required to activate the occlusion alarm(instead of five).

In some embodiments, the pump system 10 may indicate to the user thatthe detected glucose level is at an elevated state. In operation 1120,the controller device can provide an alert to the user indicating thatthe user's glucose level is elevated (refer, for example, to FIG. 1).Also, in some embodiments, the pump system 10 may indicate to the userthat the occlusion detection system was adjusted. For example, inoperation 1125, the controller device 200 can provide an alert to theuser indicating that the sensitivity of the occlusion detection systemhas been increased (refer, for example, to FIG. 1). After completion ofoperation 1125, process 1100 can return to operation 1105, entering thestand by mode. It should be understood that, after the user's bloodglucose level returns to the normal range, the sensitivity of theocclusion detection system may likewise return to a previous valuecondition (in this example, the sensitivity K value can be returned to“5”, meaning that five or more consecutive high pressure detections arerequired to activate the occlusion alarm).

In addition (or in the alternative) to the process 1100 described inconnection with FIG. 21, some embodiments of the controller device 200(employing the optical detection system 250) can operate to adjust thesensitivity of the occlusion detection system using one or moreprocesses as described in connection with FIGS. 14, 15, and 16. Forexample, the sensitivity of the optical detection system 250 can beincreased based on information indicative of a high rate of increase inthe blood glucose levels. As described in connection with FIG. 14, thecontroller device 200 can determine, based on current and previouslydetected glucose levels, a rate at which a user's blood glucose level isrising. The rate of increase in the user's blood glucose rate can thenbe compared to a predetermined threshold rate. As previously describedin connection with FIG. 14, if the determined rate is greater than thethreshold rate, the sensitivity of the optical occlusion detectionsystem 250 can be increased by decreasing the alarm sensitivity K value.

In another example, the sensitivity of the optical detection system 250can be decreased based on information indicative of low blood glucoselevels. As described in connection with FIG. 15, the controller device200 can receive measurements indicative of a user's blood glucose levelfrom the glucose monitoring device 50 and compare these measurements toa predetermined threshold value. If a detected glucose level is lessthan the threshold level, the sensitivity of the optical occlusiondetection system 250 can be decreased by increasing the alarmsensitivity K value.

In yet another example, the sensitivity of the optical detection system250 can be decreased based on information indicative of a significantrate of decrease of blood glucose levels. As described in connectionwith FIG. 16, the controller device 200 can determine, based on currentand past measured glucose data, a rate at which a user's blood glucoselevel is falling. The rate of decrease in the user's blood glucose ratecan then be compared to a predetermined threshold rate. If thedetermined rate is greater than the threshold rate, the sensitivity ofthe optical occlusion detection system 250 can be decreased byincreasing the alarm sensitivity K value.

Thus, the pump system 10 can be used to communicate informationindicative of a user's blood glucose level (or another characteristic)to the controller device 200. In such circumstances, the controllerdevice 200 can be configured to adjust the sensitivity of the occlusiondetection system based (at least in part) on the information indicativeof the user's blood glucose level. Such adjustments can be used todecrease the likelihood of false alarms when blood glucose levels are inan acceptable range, while ensuring that the user is promptly alerted topossible occlusions when the blood glucose levels are high and insulindispensation is an urgent concern.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. (canceled)
 2. A method of operating an insulin infusion pump system,comprising: activating an occlusion detection system to detect a fluidcondition in a flow path extending from an insulin reservoir in aportable insulin pump apparatus to a user, the portable insulin pumpapparatus including a pump drive system to dispense insulin through theflow path to the user; activating the pump drive system to deliver afirst incremental dosage of insulin; in response to a first signal fromthe occlusion detection system indicating an occlusion in the flow path,increasing a counter value stored in a memory device of the portableinsulin pump apparatus while foregoing output of an occlusion alarm;activating the pump drive system to deliver one or more subsequentincremental dosages of insulin; and in response to a predeterminedquantity of consecutive signals from the occlusion detection systemindicating the occlusion in the flow path, outputting the occlusionalarm from portable insulin pump apparatus to the user.
 3. The method ofclaim 2, further comprising resetting the counter value to zero inresponse to a signal from the occlusion detection system indicating noocclusion in the flow path.
 4. The method of claim 2, wherein eachsignal from the occlusion detection system indicating the occlusion isrepresentative of a detected pressure in the flow path that is greaterthan a threshold pressure limit.
 5. The method of claim 2, furthercomprising: receiving glucose information from a monitoring device, theglucose information being indicative of a detected blood glucose levelof the user; and adjusting a sensitivity of the occlusion detectionsystem based upon the glucose information from the monitoring device,wherein the sensitivity of the occlusion detection system is adjusted byaltering a value of the predetermined quantity of consecutive signalsfrom the occlusion detection system indicating the occlusion.
 6. Themethod of claim 5, wherein the sensitivity of the occlusion detectionsystem is increased in response to glucose information received from themonitoring device that indicates the detected blood glucose level isgreater than a predetermined value.
 7. The method of claim 6, furthercomprising outputting an alarm via a user interface to indicate thedetected blood glucose level is outside of a normal range.
 8. The methodof claim 6, further comprising outputting an alarm via a user interfaceto indicate a change to the occlusion detection system.
 9. The method ofclaim 5, wherein the sensitivity of the occlusion detection system isincreased in response to glucose information received from themonitoring device that indicates the detected blood glucose level isrising at a rate greater than a predetermined rate.
 10. The method ofclaim 9, further comprising outputting an alarm via a user interface toindicate a change to the occlusion detection system.
 11. The method ofclaim 5, wherein the sensitivity of the occlusion detection system isdecreased in response to glucose information received from themonitoring device that indicates the detected blood glucose level isless than a predetermined value.
 12. The method of claim 11, furthercomprising outputting an alarm via a user interface to indicate thedetected blood glucose level is outside of a normal range.
 13. Themethod of claim 11, further comprising outputting an alarm via a userinterface to indicate a change to the occlusion detection system. 14.The method of claim 5, wherein the sensitivity of the occlusiondetection system is decreased in response to glucose informationreceived from the monitoring device that indicates the detected bloodglucose level is decreasing at a rate greater than a predetermined rate.15. The method of claim 14, further comprising outputting an alarm via auser interface to indicate a change to the occlusion detection system.16. The method of claim 2, wherein the portable insulin pump apparatuscomprises: a portable pump housing that receives insulin fordispensation to the user, and a controller that provides electricalsignals to activate the pump drive system to dispense the insulin fromthe portable pump housing.
 17. The method of claim 16, wherein thecontroller operates the occlusion detection system that detects thefluid condition in the flow path.
 18. The method of claim 16, whereinthe controller is removably attachable to the portable pump housing, thecontroller comprising: a controller housing that removably attaches tothe portable pump housing, a user interface that includes a displaydevice, and an electrical connector that mates with a complementaryelectrical connector of the portable pump housing when the controllerhousing is removably attached to the portable pump housing.
 19. Themethod of claim 2, wherein the flow path comprises an insulin reservoirin which the insulin is retained, at least a portion of a cap devicethat secures to a portable pump housing of the portable insulin pumpapparatus so as to cover an external opening of the portable pumphousing, and an infusion set tube that extends from the cap device tothe user.
 20. The method of claim 2, wherein the occlusion detectionsystem comprises at least one of a pressure transducer and a pressureswitch to communicate signals to a controller of the portable insulinpump apparatus indicative of fluid pressure in the flow path of theinsulin.
 21. The method of claim 2, wherein the occlusion detectionsystem comprises an optical sensor arranged proximate to the flow pathof the insulin.